Repaglinide STADA 0,5 mg, tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

REPAGLINIDE 0,5 mg/stuk

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

A10BX02

INN (Algemene Internationale Benaming):

REPAGLINIDE 0,5 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; MAGNESIUMSTEARAAT (E 470b) ; POLOXAMEER 188,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Repaglinide

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); MAGNESIUMSTEARAAT (E 470b); POLOXAMEER 188;

Autorisatie datum:

2009-12-02

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
REPAGLINIDE STADA 0.5 MG TABLETTEN
REPAGLINIDE STADA 1 MG TABLETTEN
REPAGLINIDE STADA 2 MG TABLETTEN
REPAGLINIDE STADA 4 MG TABLETTEN
Repaglinide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Repaglinide STADA is and what it is used for
2. What you need to know before you take Repaglinide STADA
3. How to take Repaglinide STADA
4. Possible side effects
5. How to store Repaglinide STADA
6. Contents of the pack and other information
1. WHAT REPAGLINIDE STADA IS AND WHAT IT IS USED FOR
Repaglinide STADA is an _ oral antidiabetic agent_ containing
repaglinide which helps your
pancreas produce more insulin and thereby lower your blood sugar
(glucose).
TYPE 2 DIABETES is a disease in which your pancreas does not make
enough insulin to control
the sugar in your blood or where your body does not respond normally
to the insulin it produces
(formerly known _as non-insulin-dependent diabetes mellitus or
maturity onset diabetes_).
Repaglinide STADA is used to control type 2 diabetes as an add-on to
diet and exercise:
treatment is usually started if diet, exercise and weight reduction
alone have not been able to
control (or lower) your blood sugar. Repaglinide STADA can also be
given with metformin,
another medicine for diabetes.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REPAGLINIDE STADA
DO NOT TAKE REPAGLINIDE STADA:
•
If you are allergic to repaglinide or any of the other ingredients of
this medicine (listed in
section 6.)
•
If you have TYPE 1 DIABETES _(insul

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Repaglinide STADA 0,5 mg, tabletten
Repaglinide STADA 1 mg, tabletten
Repaglinide STADA 2 mg, tabletten
Repaglinide STADA 4 mg, tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Repaglinide STADA 0.5 mg tablets
Each tablet contains: 0.5 mg Repaglinide
Repaglinide STADA 1 mg tablets
Each tablet contains: 1 mg Repaglinide
Repaglinide STADA 2 mg tablets
Each tablet contains: 2 mg Repaglinide
Repaglinide STADA 4 mg tablets
Each tablet contains: 4 mg Repaglinide
Excipient(s) with known effect
Repaglinide STADA 0.5 mg tablets
Each tablet contains 0.33 mg sodium.
Repaglinide STADA 1 mg tablets
Each tablet contains 0.33 mg sodium.
Repaglinide STADA 2 mg tablets
Each tablet contains 0.66 mg sodium.
Repaglinide STADA 4 mg tablets
Each tablet contains 0.66 mg sodium.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
Repaglinide STADA 0.5 mg tablets are white, round, 3.4 mm thick and
biconvex tablets.
Repaglinide STADA 1 mg tablets are white, round, 3.4 mm thick and
biconvex tablets with
embossment “1”.
Repaglinide STADA 2 mg tablets are white, round, 4.2 mm thick and
biconvex tablets with
embossment “2”.
Repaglinide STADA 4 mg tablets are white, round, 4.0 mm thick tablets
with breaking notch
on both sides.
Repaglinide STADA 4 mg tablets can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Repaglinide is indicated in patients with type 2 diabetes (Non
Insulin-Dependent Diabetes
Mellitus (NIDDM)) whose hyperglycaemia can no longer be controlled
satisfactorily by diet,
weight reduction and exercise. Repaglinide is also indicated in
combination with metformin in
type 2 diabetes patients who are not satisfactorily controlled on
metformin alone.
Treatment should be initiated as an adjunct to diet and exercise to
lower the blood glucose in
relation to meals.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Repaglinide is given preprandially and is titrated individually to
optimise glycae